Bio Pharma Dive
MAY 31, 2023
The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.
Pharmaceutical Technology
MAY 31, 2023
XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.
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Bio Pharma Dive
MAY 31, 2023
The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.
Pharmaceutical Technology
MAY 31, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH). The company is seeking approval for the combination therapy for the long-term treatment of PAH in adult patients with World Health Organisation functional class II-III.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Bio Pharma Dive
MAY 31, 2023
The company’s experimental treatment for myotonic dystrophy became the latest neuromuscular disease therapy to face a regulatory roadblock before the start of human testing.
Pharmaceutical Technology
MAY 31, 2023
The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. Additionally, E.Coli was detected in a dose-dependent manner in feces, suggesting the therapy’s proof-of-principle targetin and removing the bacteria, including antibiotic-resistant strains.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 31, 2023
Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.
Rethinking Clinical Trials
MAY 31, 2023
Dr. John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients w
Pharmaceutical Technology
MAY 31, 2023
The University of Sydney and Australian company Pharos Therapeutics have reached an agreement to leverage artificial intelligence (AI) to progress drug discoveries for the treatment of cancer and rare diseases. The university and Pharos have drawn up a memorandum of understanding (MoU) to use AI technology to identify potential compounds for the rapid development of treatments.
Pharma Mirror
MAY 31, 2023
In the face of increasing global health challenges, the development and production of vaccines have become paramount. One critical aspect is the ability to scale up manufacturing processes to meet the growing demand for viral vector-based vaccines. In this article, we will explore the efforts being made by innovative biotechnology companies to develop scalable and cost-effective manufacturing methods.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Pharmaceutical Technology
MAY 31, 2023
ZNA-1041 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Rethinking Clinical Trials
MAY 31, 2023
Save the date! The NIH Pragmatic Trials Collaboratory will host a virtual workshop June 20-21, 2023, to explore the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems. The workshop, Getting the Right Evidence to Decision-Makers Faster , will kick off on Tuesday, June 20, at 11:00 a.m.
Pharmaceutical Technology
MAY 31, 2023
BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. According to GlobalData, Phase II drugs for Ulcerative Colitis have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BBT-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Fierce Pharma
MAY 31, 2023
Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Pharmaceutical Technology
MAY 31, 2023
Following a rocky and somewhat controversial road to securing a US Food and Drug Administration (FDA) approval, Amylyx’s amyotrophic lateral sclerosis (ALS) drug is likely to hit another regulatory snag in Europe. AMX0035, marketed as Relyvrio in the US and Abrioza in Canada, is currently awaiting approval on its marketing authorisation application (MAA) from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
XTalks
MAY 31, 2023
Warnings against high sodium intake, particularly table salt, have been consistently issued by the World Health Organization (WHO) and numerous health-promoting organizations. Now, there’s a fresh perspective from a new study that highlights not only the effects of high sodium on hypertension, but also its correlation with emotional and cognitive impairment.
Pharmaceutical Technology
MAY 31, 2023
Anocca has raised SEK 400 million ($36.7 million) in an equity financing round that will be used to move the company’s cell therapy candidates into the clinic in 2024, based on a 31 May press release. The funding will also be used to work on Anocca’s cell therapy discovery and manufacturing process. The round was led by the Swedish pension fund AMF and the investment firm Mellby Gård.
Fierce Pharma
MAY 31, 2023
FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharmaceutical Technology
MAY 31, 2023
The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The proposed “ Patient Medication Information ” guide would be an FDA-approved, one-page document that includes the necessary information for patients to understand the drug product and how to use it.
Fierce Pharma
MAY 31, 2023
After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. | After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.
Pharmaceutical Technology
MAY 31, 2023
C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China region. The agreement will cover the Hong Kong special administrative region (SAR), the Macau SAR and Taiwan. It is expected to accelerate the development of CFT8919 in important international markets.
XTalks
MAY 31, 2023
An initial public offering (IPO) is the process through which a privately held company offers its shares to the public for the first time, transforming into a publicly traded company. In the biotech industry, a biotech IPO refers to a specific case where a biotechnology company goes public and lists its shares on a stock exchange. This allows the company to raise funds from public investors.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmaceutical Technology
MAY 31, 2023
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Its favourable properties for penetrating the human brain increase intracranial activity.
Outsourcing Pharma
MAY 31, 2023
A small molecule drug candidate from Algiax Pharmaceuticals can reduce excitability of neurons in relation to chronic pain, dampening signal and reducing pain, a study shows.
Pharmaceutical Technology
MAY 31, 2023
Nadofaragene firadenovec is under clinical development by Ferring International Center and currently in Phase III for Malignant Pleural Mesothelioma. According to GlobalData, Phase III drugs for Malignant Pleural Mesothelioma have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Nadofaragene firadenovec’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmark
ProRelix Research
MAY 31, 2023
Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared first on ProRelix Research.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pharmaceutical Technology
MAY 31, 2023
GRANITE-001 is under clinical development by Gritstone Bio and currently in Phase II for Adenocarcinoma Of The Gastroesophageal Junction. According to GlobalData, Phase II drugs for Adenocarcinoma Of The Gastroesophageal Junction have a 51% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how GRANITE-001’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Pharma Times
MAY 31, 2023
The inflammatory form of arthritis is estimated to affect nearly 38 million people worldwide
Pharmaceutical Technology
MAY 31, 2023
ATRN-119 is under clinical development by Aprea Therapeutics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ATRN-119’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
pharmaphorum
MAY 31, 2023
ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research Mike.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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